BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZOLL AED PLUS

    MDR report key: 1132736 · Received August 25, 2008

    Report

    Report Number
    MW5008052
    Event Type
    Death
    Date Received
    August 25, 2008
    Date of Event
    August 22, 2008
    Report Date
    August 25, 2008
    Manufacturer
    ZOLL
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    UNIT WAS TESTED BEFORE PUT INTO SERVICE AND TESTED OK. IT WAS PLACED ON PT AND CHARGED BUT SHUT OFF BEFORE GIVING A SHOCK. CPR WAS GIVEN AND LATER EMS ARRIVED AND SHOCKED WITH THEIR DEVICE. PATIENT WAS TRANSPORTED TO MEDICAL CENTER AND PRONOUNCED EMS WAS CALLED IMMEDIATELY AND CPR COMMENCED WITHIN 2 MINUTES. REPORTER IS CONCERNED THAT THE DEVICE HAS NO WARNING AND IT CAN NOT DELIVER THE SHOCK. REPORTER BELIEVES BATTERY CAN SUPPORT DEVICE BUT DOES NOT HAVE ENOUGH POWER TO DELIVER A SHOCK. REPORTER IS INTESTESTED IN WHETHER THERE HAVE BEEN OTHER REPORTS ABOUT THIS DEVICE. THERE IS A BUTTON ON THE BACK OF THE DEFIBRILLATOR WHICH IS SUPPOSED TO BE PUSHED WHEN THE BATTERY IS CHANGED. REPORTER WONDERS IF THIS SETS A TIMER FOR NEXT BATTERY CHANGE. THERE IS NO EXPLANATION IN DEVICE'S INSTRUCTIONS FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOLL AED PLUS DEFIBRILLATOR MKJ ZOLL AED PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death ADULT PADS